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Centers for Disease Control and Prevention
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INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET is an FDA 510(k)-cleared medical device (DEN060008) manufactured by Centers for Disease Control and Prevention. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 2006. Regulation: 8.